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| Sponsored by: |
National Cancer Institute (NCI) |
| Information provided by: | National Institutes of Health Clinical Center (CC) |
| ClinicalTrials.gov Identifier: | NCT00026663 |
Purpose
This study will examine blood, bone marrow, tumor and tissue samples from patients with cancer to study tumor resistance to chemotherapy (drug treatment). Many patients with cancer improve initially with chemotherapy, but then have a disease relapse, after which their tumor no longer responds to treatment. Other patients' tumors are drug-resistant from the start. The study will look for "resistance factors"-substances in blood and tissues that render tumors resistant to chemotherapy. The findings may provide information needed to develop methods of combating drug resistance.
Patients with cancer who are 18 years or older may be eligible for this study. Participants will have 40 milliliters (3 tablespoons) of blood drawn at the beginning of the study; additional samples will be obtained periodically during the course of treatment. A small sample of tumor or normal tissue will be taken from patients who undergo surgery or tumor biopsy (removal of a small piece of tumor) for medical reasons or as part of a research treatment protocol. Patients who do not require surgery or biopsy may be asked permission to obtain a tumor sample. Depending on the location of the tumor, this may be done by: 1) withdrawing bone marrow through a small needle; 2) removing fluid from the chest or abdomen; 3) removing a small tumor sample through a needle; or 4) removing the sample with a small incision into or around the tumor. These procedures will be done only if they are of low risk to the patient.
| Condition |
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Neoplasm |
| MedlinePlus related topics: | Cancer |
| Study Type: | Observational |
| Official Title: | Collection of Blood, Bone Marrow, Tumor, or Tissue Samples From Patients With Cancer |
| Estimated Enrollment: | 100 |
| Study Start Date: | February 2000 |
| Estimated Study Completion Date: | January 2006 |
Patients with a prior diagnosis of malignancy, with advanced or refractory cancer will be evaluated in the Medical Oncology Clinic, NCI. Blood samples may be collected at the initial visit, and at followup visits. Tumor samples may be obtained by fine needle aspirate, by removal of pleural or peritoneal fluid, or by excisional biopsy, providing the tumor is accessible with a minimal risk to the patient. Specific risks will be described in a separate consent to be obtained at the time of the biopsy. Tumor samples and blood samples will be processed and stored in the Experimental and Molecular Therapeutics Sections, NCI, for use in research efforts of the Section.
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Patients 18 years of age and older are eligible.
Patients must have a performance status of ECOG 0, 1, 2, or 3 for admission to this protocol.
Patients with malignancy are eligible.
Patients requiring a surgical procedure for any medical indication can be included on study.
Patients requiring biopsy or any procedure for any medical indication can be included on study.
Patients not requiring biopsy for a medical indication can be included solely for the purpose of obtaining research samples, including blood, pleural fluid, or peritoneal fluid, or biopsy samples, providing the biopsy or aspiration procedure is of minimal risk, i.e., fine needle aspirate, bone marrow aspirate, or excisional biopsy.
EXCLUSION CRITERIA:
Pregnant patients will not be eligible due to potential risks to the fetus associated with radiologic procedures required for biopsy.
HIV patients will not be eligible since the immunodeficiency may put them at greater risk from complications due to the procedures involved in obtaining the biopsies.
Children will not be eligible because of potential risks from complications due to procedures involved in obtaining the biopsies.
Contacts and Locations| Contact: NCI Referral Office | ncissc@mail.nih.gov |
| United States, Maryland | |||||
| National Cancer Institute (NCI) | Recruiting | ||||
| Bethesda, Maryland, United States, 20892 | |||||
More Information
NIH Clinical Center Detailed Web Page
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| Study ID Numbers: | 000078, 00-C-0078 |
| First Received: | November 14, 2001 |
| Last Updated: | March 3, 2008 |
| ClinicalTrials.gov Identifier: | NCT00026663 |
| Health Authority: | United States: Federal Government |
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